Toenail fungus alone affects 2-13% of the general population of the United States; over 30% of the population over 60 years of age are affected. Current systemic treatment consists of the use of an expensive drugs or pharmaceutical agents many of which have complications and associated interactions. These pharmaceutical treatments are less than ideal for many patients because of the cost and danger associated with them.
Various approaches to treating this disease have been attempted and employed, and most involve pharmaceutical agents applied topically or systematically. For instance, U.S. Pat. No. 6,319,957 describes the use of compositions based on glyco-alcohol, hydro-alcohol or glyco-hydro-alcohol solutions of a glycol or glyceric ester of retinoic acid, preferably in association with the ethyl ester of retinoic acid and with hydroquinone, treat unsightly skin disorders such as acne, wrinkles, scars, stretch marks, dark spots, etc., and in treating mycotic skin diseases and psoriasis.
U.S. Pat. No. 6,303,140 teaches a plaster preparation comprising a synthetic rubber; a reinforcing agent based on silica or random styrene-butadiene, copolymer; a tackifier; salicylic acid or a pharmaceutically acceptable salt or ester thereof to treat mycotic infections.
U.S. Pat. No. 6,290,950 describes a new class of mycosis vaccines comprising homogenised inactivated yeast blastospores and homogenised inactivated dermatophyte microconidia or antigenic material of said spores, methods for their production and their use for the prophylaxis and/or treatment of mycoses in mammals, preferably humans. The vaccines according to the present invention are especially useful for the prophylaxis and/or treatment of skin mycosis, preferably dermatomycosis and/or candidosis and/or onychomycosis.
U.S. Pat. No. 6,287,276 describes a set depth nail notcher and method for treating nail fungus that is used to cut a notch to a predetermined depth in a nail or a toe of finger infected with fungus and then apply a topical anti-fungal medication to the toe or finger through the notch.
U.S. Pat. No. 6,281,239 teaches a method of treating onychomycosis by administering to an infected area around a nail of a patient a tissue softening composition containing urea and an antifungal composition in one or separate compositions, concurrently or non-concurrently.
Several studies have reported that electrical stimulation augments wound healing, Electrical stimulation has been reported to improve blood flow, decrease edema, and inhibit bacterial growth. Numerous studies have reported that monophasic pulsed current from a high voltage pulsed source (HVPC) augments wound healing. Additional studies have shown significant increases in transcutaneous partial pressure of oxygen (tCP O2) in diabetic individuals following use of electrical stimulation. HVPC has been used to successfully treat diabetic foot ulcers.
Several studies have demonstrated that electrical currents exist in living organisms. Cells follow the path of this current flow, which is referred to as the galvanotaxic effect. It is theorized that electrical stimulation augments the endogenous bioelectric system in the body. The increase in the rate of wound healing with electrical stimulation is also theorized to be a result of attraction of different cell types. Studies have shown that migration of macrophages, fibroblasts, mast cells, neutrophils, and epidermal cells is influenced by electrical stimulation. Electrical stimulation has also been shown to increase the proliferation of fibroblasts and protein synthesis, as well as the growth of neurites. These factors play a significant role in healing. Furthermore, the tensile strength of the collagen has been shown to increase upon application of such electrical fields, thus increasing the strength of the wound scars. For these reasons, the use of electrical stimulation for the treatment of chronic wounds has been used increasingly during the last several years.
The term onychomycosis refers to any fungal infection of one or more elements of the nail system, which consists of the nail matrix, the nail bed and the nail plate. Several studies suggest that onychomycosis affects between 2% and 18% (or possibly more) of the world's population. In North America, onychomycosis accounts for approximately 50% of all nail disease, is an infection several times more common in the toenail than the fingernail, and is most commonly found among older individuals. Some studies suggest that nearly 50% of the population over 70 years of age may be affected. The incidence of onychomycosis in the United States and other countries of the developed world has been increasing in recent years. This is thought to be most likely the result of several contributing factors including: the general aging of the population; the possible higher incidence of diabetes mellitus; the greater use of immunosuppressive drugs and antibiotics; the increased exposure of the general population to the etiologic fungi; the HIV epidemic.
Onychomycosis can be caused by three different groups of fungi: the dermatophytes, the yeasts and the nondermatophytic molds. The dermatophytes are the most common etiology, accounting for between 85% and 90% of all cases. Just two dermatophyte species, Trichophyton rubrum (T. rubrum) and Trichophyton mentagrophytes (T. mentagrophyte), are responsible themselves for nearly 80% of all cases of onychomycosis. Several different yeast species can also cause onychomycosis. These species are together responsible for between 5% and 10% all cases. In approximately 70% of these cases, the etiological agent is Candida albicans. Finally, several different species of the nondermatophyte molds can also cause onychomycosis. As a group, these are responsible for approximately 3% to 5% of all cases.
Although onychomycosis is not a fatal infection, and is usually not a very debilitating condition in most afflicted individuals, it can still have serious emotional and/or physical consequences. The condition can be associated with significant pain and discomfort, and in severe cases, it may sometimes lead to disfigurement and/or to various degrees of functional loss. In addition to physical impairment, the psychological and social consequences of onychomycosis can also be significant. Thus, onychomycosis represents far more than a mere cosmetic problem for many afflicted individuals, and professional treatment from health care providers is very often sought.
The treatment of onychomycosis, however, has proven difficult. The three traditional approaches to treatment are debridement of the nail unit, topical medication and systemic chemotherapy. The most successful of these approaches has been the use of systemic antifungal drugs. Over the last 40 years, oral systemic antifungal agents have been the mainstay of onychomycosis therapy. However, because of several negative factors that include drug toxicity, possible adverse interactions of antifungal agents with other drugs in the body, and the prolonged course of treatment required with many of these antifungal therapeutic regimes, the search for new, alternative treatments, which are both efficacious and which present minimal side effects, is still an important research goal.